NCT03051607

Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease.

A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease Experiencing End of Dose "Wearing-Off"

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Biotie Therapies Inc. · Industry
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Phase 3, international, multicenter, open-label 12 month safety study.

Detailed description

Each patient will participate for up to 52 weeks, which includes a Screening Period, followed by a Baseline Visit and open-label treatment for 1 year with a safety Follow-up 4 weeks after the last treatment. * Screening Period: up to 6 weeks. * Open-Label Treatment Period: 52 weeks (1 year) * Post-Treatment Safety Follow Up: 4 weeks.

Conditions

• Idiopathic Parkinson Disease

Interventions

Type	Name	Description
DRUG	Tozadenant	1 Year Open Label, 120 mg BID tozadenant, with dose modification to 60 mg BID tozadenant permitted.

Timeline

• Start date: 2017-04-10
• Primary completion: 2018-01-16
• Completion: 2018-01-16
• First posted: 2017-02-13
• Last updated: 2019-05-03
• Results posted: 2019-05-03

Locations

35 sites across 3 countries: United States, Canada, United Kingdom

Regulatory

• FDA-regulated drug study